Advancing Drug Development by Reducing Reliance on Animal Testing
Case Example: Pre-Clinical Animal Models in Lung Toxicology

Hybrid Public Meeting
February 26, 2026 | 10am-4pm (eastern)

Reducing reliance on animal testing has become an important scientific and regulatory priority, reflecting growing recognition that traditional animal models may lack sufficient human relevance and slow the development of safe and effective therapies.

On February 26, 2026, the Reagan-Udall Foundation for the FDA will convene a hybrid public meeting on Advancing Drug Development by Reducing Reliance on Animal Testing. We invite you to join this meeting, which will bring together voices from academia, the research community, regulators, and regulated industry to examine the challenges that reliance on animal-based safety assessments can present for medication innovation as well as patients. Using animal models in inhalation toxicology as a representative case study, speakers will explore how practical, human-relevant alternatives to rat testing, including FDA-supported New Approach Methodologies, may establish human safety without imposing unnecessary constraints on the progression of development programs. In parallel, the meeting seeks to explore opportunities to align global regulatory expectations for inhalation toxicology and translation to clinic.

View Speaker Bios

View Meeting Slide Deck

Agenda

10am

Welcome and Opening Remarks

Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

Steven Kozlowski, MD, Chief Scientist - Office of the Chief Scientist, Office of the Commissioner, FDA

10:15am

Use of Animal Models in Pre-Clinical Lung Toxicology Safety Studies: Current Expectations and Limitations

Speakers:

  • Matt Reed, PhD, DABT, Consultant, Coelus LLC
  • Jeff Tepper, PhD, DABT, Consultant, Tepper Nonclinical Consulting

11am

Industry Experience in Current Environment

Speakers:

  • William Thelin, PhD, Senior Vice President, Aer Therapeutics
  • Jorrit Hornberg, PhD, MSc, Vice President, Global Head of Safety Sciences, AstraZeneca
  • Per Aberg, MSc, Senior Director of Toxicology, AstraZeneca
  • Aidan Curran, PhD, Principal, Curran Nonclinical Consulting

11:45am

Panel Discussion: Impact of Current Environment on Product Development and Patients

Reactor Panelists:

  • Teresa Barnes, Chief Executive Warrior, PF Warriors
  • Karin Hoelzer, DVM, PhD, Senior Director, Patient Advocacy, BIO

12:30pm

Lunch

1:15pm

Innovations in Lung Toxicology Safety Studies: New Approaches in Pre-Clinical Models and Clinical Monitoring

Speakers:

  • Mary McElroy, PhD, MBA, Head - Discovery Pharmacology and Toxicology, Charles River Laboratories
  • Alexandra Maertens, PhD, Assistant Professor - Bloomberg School of Public Health, Johns Hopkins University
  • Megan LaFollette, PhD, Executive Director, 3Rs Collaborative
  • Emily Richardson, PhD, Biology Group Leader, CN Bio
  • Rachel Eddy, PhD, Imaging Scientist, Clinical Development, VIDA
  • John Fahy, MD, MSc, Professor of Medicine - Division of Pulmonary and Critical Care Medicine, University of California-San Francisco

2:45pm

What the Future Might Look Like

Panelists:

  • Lorna Ewart, PhD, DSC, Chief Scientific Officer, Emulate
  • Andrew Goodwin, PhD, Director - Division of Pharmacology-Toxicology for Immunology and Inflammation, FDA
  • David Jones, FRSB, FBTS, Consultant, ApconiX
  • Tim McGovern, PhD, Principal Consultant, White Oak Regulatory Tox
  • Steve Rowe, MD, CSO, Cystic Fibrosis Foundation

3:55pm

Closing Remarks

Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

4pm

Adjourn

Aer Therapeutics, Avalyn Pharma, Inc., Biotechnology Innovation Organization, Charles River Laboratories, Endeavor BioMedicines, Ionis Pharmaceuticals, and VIDA provided funding for this meeting.